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随机可行性试验的帮助家庭计划修改版:一个强化养育干预,针对受严重人格障碍影响的父母。

Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.

机构信息

Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK

Centre for Parent and Child Support, South London and Maudsley NHS Foundation Trust, London, UK.

出版信息

BMJ Open. 2020 Feb 6;10(2):e033637. doi: 10.1136/bmjopen-2019-033637.

Abstract

BACKGROUND

Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties.

OBJECTIVE

Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention.

DESIGN

Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates.

SETTINGS

Two National Health Service health trusts and local authority children's social care.

PARTICIPANTS

Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties.

INTERVENTION

HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session.

OUTCOMES

Primary feasibility outcome: participant retention rate.

SECONDARY OUTCOMES

(i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory).

SECONDARY OUTCOMES

child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation.

RESULTS

Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3).

CONCLUSION

HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported.

TRIAL REGISTRATION NUMBER

ISRCTN14573230.

摘要

背景

专门的育儿干预可以改善受严重人格障碍影响的父母的育儿和儿童心理健康问题。

目的

对专门的育儿干预措施——改良版育儿家庭计划(Helping Families Programme-Modified,HFP-M)进行可行性试验。

设计

实用、混合方法试验,1:1 随机分组,评估可行性、干预接受度和结果估计。

设置

两个国民保健服务医疗信托基金和地方当局儿童社会关怀机构。

参与者

父母:(i)主要照顾者,(ii)18 至 65 岁,(iii)严重人格障碍,(iv)精通英语,(v)有同意能力。儿童:(i)3 至 11 岁,(ii)与主要家长同住,(iii)存在明显的情绪/行为障碍。

干预措施

HFP-M:16 节家庭为基础的干预措施,采用育儿和治疗性参与策略。常规护理:标准护理,辅以单一的心理教育性育儿课程。

结果

主要可行性结果:参与者保留率。

次要结果

(i)招募、资格和数据完成率,(ii)干预接受率、完成率和联盟率(工作联盟量表-简短修订版)。主要临床结果:儿童行为(Eyberg 儿童行为量表)。

次要结果

儿童心理健康(对孩子的担忧、儿童行为检查表-内化量表)、育儿(Arnold-O'Leary 育儿量表、堪萨斯父母满意度量表)和父母心理健康(症状清单-27)。定量数据是在不了解分配的情况下收集的。

结果

研究结果广泛支持非诊断性选择标准。在招募的 48 名参与者中,有 32 名在平均 42 周后完成了干预后的测量。参与者保留率超过了事先设定的比率(HFP-M=18;常规护理=14;66.7%,95%置信区间 51.6%至 79.6%)。HFP-M 是可以接受的,其交付时间比计划的要长。常规护理的联盟评级较低。试验组中均检测到儿童和育儿结果的影响,HFP-M 具有潜在优势(效应大小范围:0.0 至 1.3)。

结论

HFP-M 是一种可接受且可能有效的专门育儿干预措施。在考虑招募和保留方法、干预效率和对照组条件的情况下,进行一项确定性试验是可行的。由于样本量减少,结果的解释需谨慎。没有报告严重不良事件。

试验注册号

ISRCTN8655360。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4986/7045220/32c904fe61bb/bmjopen-2019-033637f01.jpg

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